AK112 Plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC

Launched by HUNAN PROVINCE TUMOR HOSPITAL · Dec 25, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with a type of lung cancer called non-small cell lung cancer (NSCLC) who have specific genetic markers (EGFR, ALK, or ROS1) and have not responded to their initial treatment. Researchers want to see how well a combination of a new drug called AK112, which targets certain proteins in the immune system, works alongside standard chemotherapy. The trial is currently not recruiting participants, but it aims to enroll adults aged 18 to 75 who are in relatively good health (with an ECOG score of 0 or 1, which measures how well they can perform daily activities).

Eligible participants will be divided into three groups based on their specific cancer type: those with EGFR mutations, ALK fusions, or ROS1 fusions. Each group will receive the new treatment and undergo regular monitoring for safety and effectiveness. Before joining the trial, potential participants will need to provide informed consent and meet specific health criteria. It's important to note that individuals with certain types of lung cancer or those who have received specific prior treatments may not be eligible. Participants can expect to be closely monitored throughout the trial to assess how well the treatment is working and to track any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Eligible subjects selected for this study must meet all of the following criteria:
• • 1. Sign written informed consent before implementing any trial-related procedures;
• • 2. Age ≥18 years old and ≤75 years old;
• • 3. No limit on the gender;
• • 4. The ECOG score is 0 or 1.
• • The investigators want to evaluated the Efficay and Satety of PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC who Failed from First-Line Standard Treatment.
• • This study will be devided into three cohorts.
• • Cohort A for EGFR mutation NSCLC, Patient with NGS idenfied EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included. The 3+3 stud will conducted for dose escalation for AK112 （from 20mg to 30mg), and than the fix dose will be set up for cohort A, B and C.
• • Cohort B for ALK fusion NSCLC, Patient with NGS idenfied ALK fusion NSCLC who failed from first line Alectinib will be included. All the patients will be devided two group,3'ALK and 3'ALK with reteintion of 5'ALK. All the patients will be treated with PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.
• • Cohort C for ROS1 fusion NSCLC, Patient with NGS idenfied ROS1 fusion NSCLC who failed from first line crizotinib or Entrectinib will be included. All the patients will be treated with PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.
• • The investigators will collect the satety and efficacy data for all the patients.
• Exclusion Criteria:
• • Histological or cytological pathology confirmed the presence of a small cell carcinoma component, or a squamous cell carcinoma as a major component
• • Patients who have received immunotherapy previously, including immune checkpoint inhibitors (such as anti-PD-1/L1, anti-CTLA-4 , anti-LAG-3, etc.), immune checkpoint activators (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy and any other treatment targeting the immunity mechanism.
• • Previously received other anti-tumor therapy for advanced stages of NSCLC (stages IIIB to IV) (including cytotoxic chemotherapy used with radiotherapy, systemic chemotherapy, and anti-VEGFR therapy) .
• • Patients who have previously undergone adjuvant/neoadjuvant chemotherapy with the aim of curing non-metastatic diseases are eligible for inclusion in this study if disease progression occurs at least 6 months after the completion of the last chemotherapy cycle.
• • Concurrent enrollment in another clinical trial is allowed, unless it involves a non-interventional clinical study or the follow-up period of an interventional study (defined as the time elapsed from the initiation of the first drug to at least 4 weeks after the last drug administration in the previous clinical study or beyond 5 half-lives of the investigational drug in that study, whichever is shorter).
• • Received TKI treatment within the 2 weeks preceding the first dose; underwent palliative local therapy for non-target lesions within the 2 weeks preceding the first dose; received non-specific immunomodulatory therapy within the 2 weeks preceding the first dose, such as interleukins, interferons, thymosin alpha-1, tumor necrosis factor, etc. (excluding IL-11 used for treating thrombocytopenia); received herbal medicine or traditional Chinese medicine with anti-tumor indications within the 1 week preceding the first dose.